Plain English Summary

Background and study aimsDementia is a broad category of brain diseases that cause a long-term gradual decrease in the ability to think and remember that affects a person's daily functioning. Evidence shows that treatment in a small scaled home-like Special Care Unit (SCU) can have positive effects on the behavioral and psychological symptoms of patients with dementia. Aspects of cognition (thinking), rest/activity, mood and medication use are scarcely investigated. The aim of this study is to gain more insight into the effects of living in a small-scale home-like SCU compared to a regular traditional SCU for residents with dementia.

Who can participate? Patients aged 65 – 100 with dementia living in two regular SCUs

What does the study involve? Participants living in one of the SCUs move to a small scaled home-like SCU (intervention group) and the participants in the other SCU stay at their regular SCU (control group). The participants’ cognitive functions, rest/activity, mood and medication use are assessed with tests, observations, questionnaires and information from medical files. All the data are collected 3 months before, 3 months after and 6 months after the relocation of the intervention group.

What are the possible benefits and risks of participating? No benefits or risks are expected for the participants.

Where is the study run from? Dignis|Lentis - Nursing home 'De Enk' (Netherlands)

When is the study starting and how long is it expected to run for? June 2009 to December 2012

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

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Study information

Scientific title

A longitudinal controlled trial comparing patients with dementia living in a regular special care unit with patients with dementia living in a small scaled home-like special care unit

Acronym

Study hypothesis

The aim of the study is to investigate the possible positive effects on patients with dementia of living in a small scaled homelike special care unit (SCU) on cognition, rest/activity, mood, quality of life and medication use compared to patients with dementia living in a regular special care unit.

Ethics approval

The Ethical Committee of the Department of Psychology of the University of Groningen, 03/06/2009, ref: PPO-008-093

Study design

Longitudinal quasi-experimental field study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Dementia

Intervention

The patients were living in two different nursing homes before the study started. Patients of the intervention group were relocated from their regular SCU to a small-scale home-like SCU due to organizational reasons (the building no longer met the requirements of the current healthcare standards). The control group stayed in their regular SCU during the study. All measurements were conducted at baseline (3 months before intervention), follow up 1 (3 months after intervention) and follow up 2 (6 months after intervention).

Intervention type

Other

Phase

Drug names

Primary outcome measures

All measurements conducted at baseline (3 months before intervention), follow up 1 (3 months after intervention) and follow up 2 (6 months after intervention).

1. Cognition: 1.1. Cognitive status, assessed using the Dutch version of the Standardized Mini-Mental State Examination1.2. Verbal memory, assessed using the Eight Word Verbal Memory Test of the Amsterdam Dementia Screening Test (ADS)1.3. Visual memory, recognition of pictures and recognition of faces, assessed using two subtests of the Rivermead Behavioural Memory Test (RBMT)1.4. Language functioning, assessed using the shortened Boston Naming Test-15 (BNT)1.5. Different aspects of praxis, assessed using the diagnostic test for apraxia of van Heugten1.6. Executive control, measured using the Trail Making Test A and B, The Category Fluency Task from the Groningen Intelligence Test (GIT) and a Clock Drawing test1.7. Figure recognition, assessed using a subtask of the GIT, Incomplete Drawings1.8. Aspects of cognition, observed by nursing personnel with a behavioural observation scale for intramural psychogeriatry (GIP)1.9. Cognitive decline, measured using the Information Questionnaire on Cognitive Decline in the Elderly

Sponsor details

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Website

Funders

Funder type

Hospital/treatment centre

Funder name

Lentis

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Location

Results and Publications

Publication and dissemination plan

1. Rest-activity Rhythms in Small Scale Homelike Care and Traditional Care for Residents with Dementia: July 20172. Quality of life and mood in small scaled homelike nursing homes: a 1-year follow up study: September 20173. Medication use in small scaled homelike nursing homes: a 1-year follow up study: January 2018

IPD sharing statementThe datasets generated during and/or analysed during the current study are/will be available upon request from Mr Jeroen Kok